ULTRA STRENGTH PAIN RELIEF BALM (CAMPHOR MENTHOL OINTMENT) OINTMENT [MCURE HEALTH SOLUTIONS]

ULTRA STRENGTH PAIN RELIEF BALM (CAMPHOR MENTHOL OINTMENT) OINTMENT [MCURE HEALTH SOLUTIONS]
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NDC 52486-320-18
Set ID 4b2d92e8-5648-1c21-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager MCURE HEALTH SOLUTIONS
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredients Purpose

    Camphor 11%........................................................ Topical analgesic

    Menthol 11%.......................................................... Topical analgesic

  • PURPOSE

    Uses

    For temporary relief of minor aches and pains of muscles and joints associated with over-exertion, simple backache, arhtritis, strains, and spraings

  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product

    • Avoid contact with the eyes and mucous membranes
    • Do not apply to open wounds or damaged skin
    • Do not bandage or use heating pad
  • STOP USE

    Stop use and ask a doctor if

    • Condition worsens
    • Severe skin irritation occurs
    • Pain persists for more than seven days
    • Pain clears up and then recurs a few days later
  • ASK DOCTOR

    If pregnant or breast feeding, ask a healthcare professional before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
    If swallowed get medical help or contact a Poison Control Center immediately

  • INDICATIONS & USAGE

    Directions

    • Rub well on the affected area. Repeat 3 to 4 times dailys.
    • For children 2-12 years, consult a doctor before use
  • STORAGE AND HANDLING

    Other information
    This product may cause allergic reaction in some individuals. Test on small area before use.

  • INACTIVE INGREDIENT

    Inactive ingredients
    cajuput oil, clove oil, dementholized mint oil, paraffin petrolatuma

  • DOSAGE & ADMINISTRATION

    Distributed by:
    MCURE HEALTH SOLUTIONS INC.
    20819 Currier Rd #200
    City of Industry, CA 91789
    Made in China

  • PRINCIPAL DISPLAY PANEL

    PAIN RELIEF BALM

  • INGREDIENTS AND APPEARANCE
    ULTRA STRENGTH PAIN RELIEF BALM 
    camphor menthol ointment ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52486-320
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL11 g  in 100 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)11 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CAJUPUT OIL (UNII: J3TO6BUQ37)  
    CLOVE OIL (UNII: 578389D6D0)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52486-320-1818 g in 1 BOTTLE; Type 0: Not a Combination Product03/20/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/20/2017
    Labeler - MCURE HEALTH SOLUTIONS (053034873)
    Establishment
    NameAddressID/FEIBusiness Operations
    Suzhou Vastech Medical Technology Co., Ltd543772485manufacture(52486-320)

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